MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION; REF XLPE 36 20 DEG 58-60 G

Catalog Number 71333346

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/10/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.

Manufacturer Narrative

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the returned devices noted the devices are intact and resemble typical explanted devices.A review of complaint history revealed no prior complaints for the listed lots/failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.An evaluation performed by our research lab revealed the returned devices showed bone on-growth on the shell.It also noted burnishing on the shell, possibly due to the reported bone loss.Damage was noted on the articulating surface of the liner, which was likely caused during removal.No material or manufacturing deviations were observed during this investigation.Our investigation could not determine a specific cause of the failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: REFLECTION
• Type of Device: REF XLPE 36 20 DEG 58-60 G
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: conne mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 4116787
• MDR Text Key: 4920648
• Report Number: 1020279-2014-00584
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: K022902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 71333346
• Device Lot Number: 09CM09731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization